Covid19HLA-G-COVIDNCT04613297
HLA-G Immuno-Inhibitor Checkpoint Study in Patients With COVID-19 Infection: Molecular and Cellular Assessment
A study testing Baseline and during hospitalization blood samples and Baseline blood sample in people with Covid19, run by Hopital Foch at 1 site in France.
Trial summary
The aim of the research is to study the immune checkpoint linked to the HLA-G molecule in the dysregulation of the control of COVID-19 infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- What is being tested?
- Baseline and during hospitalization blood samples and Baseline blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteFrance
- Study dates
- 19 Oct 2020to 19 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with possible or confirmed infection by COVID-19
Who cannot join
- Patient without liberty or guardianship
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the research is to study the immune checkpoint linked to the HLA-G molecule in the dysregulation of the control of COVID-19 infection.
Read the detailed description
Single-center, prospective, open-ended, interventional study with minimal risks and constraints. Patients will be divided into 3 groups: patients not infected with COVID-19, patients infected with COVID-19 not hospitalized, patients infected with COVID-19 hospitalized.
- Conditions
- Covid19
- Being tested
- Baseline and during hospitalization blood samples, Baseline blood sample
- Keywords
- HLA-G
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline and during hospitalization blood samplesOther
Blood sample will be performed at the inclusion visit for all patient and for the hospitalized COVID-19 infected patients, extra-blood samples will be performed :
- at day 3
- day 5 and
- In case of aggravation
- At the discharge from hospital
Baseline blood sampleOther
Blood sample will be performed at the inclusion visit only
| Study group | Role | What they receive |
|---|---|---|
| COVID-19 uninfected patients | Other | Patient with negative PCR result Receives: Other: Baseline blood sample |
| non-hospitalized COVID-19 infected patients | Other | Patient with positive PCR result who does not require hospitalization for COVID-19 Receives: Other: Baseline blood sample |
| hospitalized COVID-19 infected patients | Other | Patient with positive PCR who require hospitalization for COVID-19 Receives: Other: Baseline and during hospitalization blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the percentage of T cells expressing the HLA-G receptor ILT2 (CD3+CD4+ILT2+ T cells, and CD3+CD8+ILT2+ T cells) between the 3 groups of patients.
The CD3 + T lymphocyte cell populations (CD4 + ILT2 + and CD8 + ILT2 +) will be compared between the groups of patients
Measured: 1 month
Comparison of the expression of circulating soluble HLA-G, between the groups of patients.
Blood levels of soluble HLA-G and plasma microvesicles with expression of HLA-G will be compared between the groups of patients.
Measured: 1 day
Secondary outcomes (3)
1 month survival
Vital status collected 1 month post inclusion for all the patients
Measured: 1 month
Assessment of the severity of the disease according to the isoform of HLA-G
Comparison of the isoforms (alleles) of HLA-G regarding the severity of the disease for the infected patients.
Measured: 1 month
Comparison of the expression of one of the cell receptors of the SARS-CoV-2 virus, called BSG (Basigin), whose expression is modified by the interaction between HLA-G.
The expression of the BSG cell receptor induced by HLA-G will be compared between COVID19 patients and uninfected patients.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2020
- Study start19 Oct 2020
- Primary completion19 Jul 2022
- Study completion19 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier BRUGIERE, PhD, Principal investigator, Hopital Foch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04613297
- Sponsor's protocol ID
- 2020_0082
- Acronym
- HLA-G-COVID
- Status last verified
- Aug 2022
- First submitted
- 2 Nov 2020
- Last updated
- 3 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HLA-G Immuno-Inhibitor Checkpoint Study in Patients With COVID-19 Infection: Molecular and Cellular Assessment
- ClinicalTrials.gov ID
- NCT04613297
- Acronym / sponsor ID
- HLA-G-COVID / 2020_0082
- Conditions
- Covid19
- Keywords
- HLA-G
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 19 Jul 2022 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 3 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the research is to study the immune checkpoint linked to the HLA-G molecule in the dysregulation of the control of COVID-19 infection.
Detailed description
Single-center, prospective, open-ended, interventional study with minimal risks and constraints. Patients will be divided into 3 groups: patients not infected with COVID-19, patients infected with COVID-19 not hospitalized, patients infected with COVID-19 hospitalized.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| COVID-19 uninfected patients | Other | Other: Baseline blood samplePatient with negative PCR result |
| non-hospitalized COVID-19 infected patients | Other | Other: Baseline blood samplePatient with positive PCR result who does not require hospitalization for COVID-19 |
| hospitalized COVID-19 infected patients | Other | Other: Baseline and during hospitalization blood samplesPatient with positive PCR who require hospitalization for COVID-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with possible or confirmed infection by COVID-19
Key exclusion criteria (1 listed)
- Patient without liberty or guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baseline and during hospitalization blood samplesBlood sample will be performed at the inclusion visit for all patient and for the hospitalized COVID-19 infected patients, extra-blood samples will be performed : * at day 3 * day 5 and * In case of aggravation * At the discharge from hospital | Other | hospitalized COVID-19 infected patients |
| Baseline blood sampleBlood sample will be performed at the inclusion visit only | Other | COVID-19 uninfected patients, non-hospitalized COVID-19 infected patients |
Primary outcome
Comparison of the percentage of T cells expressing the HLA-G receptor ILT2 (CD3+CD4+ILT2+ T cells, and CD3+CD8+ILT2+ T cells) between the 3 groups of patients.
Time frame: 1 month
The CD3 + T lymphocyte cell populations (CD4 + ILT2 + and CD8 + ILT2 +) will be compared between the groups of patients
Comparison of the expression of circulating soluble HLA-G, between the groups of patients.
Time frame: 1 day
Blood levels of soluble HLA-G and plasma microvesicles with expression of HLA-G will be compared between the groups of patients.
3 secondary outcomes
1 month survival
Time frame: 1 month
Assessment of the severity of the disease according to the isoform of HLA-G
Time frame: 1 month
Comparison of the expression of one of the cell receptors of the SARS-CoV-2 virus, called BSG (Basigin), whose expression is modified by the interaction between HLA-G.
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier BRUGIERE, PhD principal investigator
Hopital Foch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline and during hospitalization blood samples and Baseline blood sample in people with Covid19, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the percentage of T cells expressing the HLA-G receptor ILT2 (CD3+CD4+ILT2+ T cells, and CD3+CD8+ILT2+ T cells) between the 3 groups of patients. (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2022.